This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who have their valve replaced through aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle. In many patients even after an AVR, the heart still is unable to pump as well and can lead to heart failure. This study will assess if medication used in other causes of heart failure can help patients having an AVR recover better. It will assess two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS. We hope that taking one or both medicines together will help patients with AS. There will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months. Participants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit. These medicines might help patients after AVR by reducing heart muscle thickness and scarring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
445
One tablet of Dapagliflozin once a day for the duration of the trial - 12 months (52 weeks).
One tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).
One tablet of Dapagliflozin and one tablet of Spironolactone once a day for the duration of the trial - 12 months (52 weeks).
If a participant experiences significant side effects of Spironolactone they will be switched to Epleronone in line with clinical care.
Change in the left ventricular mass indexed from pre Aortic Valve Replacement (AVR) to 12 months post AVR
Left ventricular mass indexed (LVMi) measured by cardiac MRI in g/m2.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.